CSV QA

CSV QA Engineer - Description: Candidate must have 1 to 3 years of industrial experience in a reputed Pharma /Life science domain Candidate must have an equivalent combination of working experience in QA activities along with IT and CSV domains. Work experience in both the IT sector and the pharma sector will be desirable. Hands-on experience and knowledge of various software (including manufacturing, laboratory, enterprise, SAP, warehouse, etc.) Experience in validation on automation/digitization projects In-depth knowledge of various following regulatory guidance 21 CFR Part 11, Electronic Records; Electronic Signatures Annex 11: Computerized Systems, European Commission, Health and Consumers Directorate-General GAMP 5: Good Automated Manufacturing Practices WHO, MHRA USFDA guidance ICH Q7, Q8, Q9 Q10 Data integrity guidance A team leader with good communication skills (verbal and written), good documentation and technical writing skills, Good logical thinking, problem-solving, and decision-making skills Candidate should have good exposure to handling CSV for the enterprise application like SAP, Track wise Project Location 1 MAH | MUMBAI Relevant Experience 5 Mandatory skills Candidate must have an equivalent combination of working experience in CQA activities along with IT and CSV domains Desired skills #21 CFR Part 11, Electronic Records; Electronic Signatures Annex 11: Computerized Systems, European Commission, Health and Consumers Directorate-General #GAMP 5: Good Automated Manufacturing Practices Domain (Industry) Pharma(CQA) Total Experience (Ex. 5-7 Years) 3-5yrs WFO / WFH / Hybrid WFO Please enter shift timings 9-6 Shift Timings General Location- Airoli, Navi Mumbai Yrs of Exp-3+Yrs ", Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.